MannKind Corporation (Nasdaq: MNKD) today reported
financial results for the quarter ended June 30, 2023.
“We are excited to report positive income from operations in the
second quarter driven by growing patient demand for Tyvaso DPI® and
Afrezza as well as manufacturing revenues from Tyvaso DPI,” said
Michael Castagna, PharmD, Chief Executive Officer of MannKind
Corporation. “In addition, we have optimized our commercial
operations supporting Afrezza® and V-Go®, which is expected to get
our Endocrine Business Unit to profitability starting in 2024.”
Second Quarter 2023 Results
Revenue Highlights
|
|
Three Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
|
|
(Dollars in thousands) |
|
Net revenue – Afrezza |
|
$ |
13,527 |
|
|
$ |
10,649 |
|
|
$ |
2,878 |
|
|
|
27 |
% |
Net revenue – V-Go |
|
|
4,818 |
|
|
|
2,073 |
|
|
$ |
2,745 |
|
|
* |
|
Revenue – collaborations and
services |
|
|
11,211 |
|
|
|
5,868 |
|
|
$ |
5,343 |
|
|
|
91 |
% |
Royalties – collaborations |
|
|
19,055 |
|
|
|
304 |
|
|
$ |
18,751 |
|
|
* |
|
Total revenues |
|
$ |
48,611 |
|
|
$ |
18,894 |
|
|
$ |
29,717 |
|
|
|
157 |
% |
________________________* Not meaningful
Afrezza net revenue for the second quarter of 2023 increased
$2.9 million, or 27%, compared to the same period in 2022 as a
result of higher product demand and price. V-Go was acquired in the
second quarter of 2022 and achieved $22.0 million in cumulative net
revenues one year post-acquisition, which was at the high end of
our forecasted range. The increase in collaborations and services
revenue was primarily attributable to revenues associated with the
commercial supply agreement (the "CSA") with United Therapeutics
("UT"). In the second quarter of 2022, revenue associated with the
CSA was deferred until we began commercial manufacturing and
subsequently selling Tyvaso DPI in June 2022. Royalties related to
Tyvaso DPI, launched in late second quarter of 2022 by UT, were
$19.0 million in the second quarter of 2023 and continued to grow
based on strong patient demand.
Commercial product gross margin in the second quarter of 2023
was 72% compared to 64% for the same period in 2022, primarily
attributable to an increase in Afrezza net revenue, which has a
higher gross margin than V-Go.
Cost of revenue – collaborations and services for the second
quarter of 2023 was $9.0 million compared to $8.3 million for the
same period in 2022, an increase of $0.7 million, due to an
increase in manufacturing activities for Tyvaso DPI.
Research and development ("R&D") expenses for the second
quarter of 2023 were $6.5 million compared to $4.9 million for the
same period in 2022. The $1.6 million increase was primarily
attributed to development activities for MNKD-101 (inhaled
clofazimine) and an Afrezza post-marketing clinical study
(INHALE-3), which commenced in the second quarter of 2023.
Selling expenses for the second quarter of 2023 were $14.0
million compared to $15.9 million for the same period in 2022. The
$1.9 million decrease was primarily attributable to the termination
of an Afrezza pilot promotional effort targeting primary care
physicians, which ended in the third quarter of 2022, partially
offset by increased headcount after the acquisition of V-Go in the
second quarter of 2022.
General and administrative expenses for the second quarter of
2023 were $11.9 million compared to $10.2 million for the same
period in 2022. The $1.8 million increase was primarily
attributable to higher stock-based compensation and increased
headcount.
Interest income was $1.5 million for the second quarter of 2023
compared to $0.5 million for the same period in 2022. The
increase was primarily due to higher yields on our marketable
securities and money market funds.
Interest expense on financing liability was $2.4 million for the
second quarter of 2023 and remained consistent with the same period
in 2022.
Interest expense was $6.9 million in the second quarter of 2023
compared to $6.6 million for the same period in 2022, which
remained consistent due to fixed interest rates on notes and
consistent recognition of interest expense related to the
achievement of Afrezza milestones.
Gain on available-for-sale securities for the second quarter of
2023 was $0.9 million as a result of the change in the fair value
of the investment that related to credit risk.
First half of 2023
Revenue Highlights
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
$ Change |
|
|
% Change |
|
Net revenue — Afrezza |
|
$ |
25,951 |
|
|
$ |
20,475 |
|
|
$ |
5,476 |
|
|
|
27 |
% |
Net revenue — V-Go |
|
|
9,956 |
|
|
|
2,073 |
|
|
$ |
7,883 |
|
|
* |
|
Revenue — collaborations and
services |
|
|
22,597 |
|
|
|
8,034 |
|
|
$ |
14,563 |
|
|
|
181 |
% |
Royalties — collaborations |
|
|
30,733 |
|
|
|
304 |
|
|
$ |
30,429 |
|
|
* |
|
Total revenues |
|
$ |
89,237 |
|
|
$ |
30,886 |
|
|
$ |
58,351 |
|
|
|
189 |
% |
________________________* Not meaningful
Afrezza net revenue for the first half of 2023 increased $5.5
million, or 27%, compared to the same period in 2022 primarily as a
result of higher product demand and price. V-Go was acquired in the
second quarter of 2022 and achieved $22.0 million in net revenues
one year post-acquisition, which was at the high end of our
forecasted range. The increase in collaborations and services
revenue was primarily attributable to the deferral of revenue
associated with the CSA until we began commercial manufacturing and
subsequently selling Tyvaso DPI in June 2022. Royalties related to
Tyvaso DPI, launched in the late second quarter of 2022 by UT,
reached $30.7 million in the first half of 2023 based on strong
patient demand.
Commercial product gross margin in the first half of 2023 was
70%, which was consistent with the same period in 2022.
Cost of revenue – collaborations and services for the first half
of 2023 was $19.7 million compared to $17.0 million for the same
period in 2022, an increase of $2.7 million, due to an increase in
manufacturing activities for Tyvaso DPI.
R&D expenses for the first half of 2023 were $12.1 million
compared to $8.4 million for the same period in 2022. The $3.6
million increase was primarily attributed to development activities
for MNKD-101 and INHALE-3.
Selling expenses for the first half of 2023 were $27.3 million
compared to $28.6 million for the same period in 2022. The $1.3
million decrease was primarily due to the termination of an Afrezza
pilot promotional effort targeting primary care physicians, which
ended in the third quarter of 2022, partially offset by increased
headcount and promotional expenses after the acquisition of V-Go in
the second quarter of 2022.
General and administrative expenses for the first half of 2023
were $22.5 million compared to $18.1 million for the same period in
2022. The $4.3 million increase was primarily attributable to
higher stock-based compensation and increased headcount.
Interest income was $2.8 million for the six months ended June
30, 2023 compared to $0.9 million for the same period in
2022. The increase was primarily due to higher yields on our
marketable securities and money market funds.
Interest expense on financing liability was $4.9 million for the
first half of 2023 and remained consistent with the same period in
2022.
Interest expense on notes was $9.7 million in the first half of
2023 compared to $9.4 million for the same period in 2022, which
remained consistent due to fixed interest rates on notes and
consistent recognition of interest expense related to the
achievement of Afrezza milestones.
Gain on available-for-sale securities for the first half of 2023
was $0.9 million as a result of the change in the fair value of the
investment that related to credit risk.
Cash, cash equivalents and investments as of June 30, 2023
were $146.6 million.
Non-GAAP Measures
To supplement our unaudited condensed consolidated financial
statements presented under U.S. generally accepted accounting
principles (GAAP), we are presenting non-GAAP income (loss) from
operations, non-GAAP net loss and non-GAAP net income (loss) per
share, which are non-GAAP financial measures. We are providing
these non-GAAP financial measures to disclose additional
information to facilitate the comparison of past and present
operations, and they are among the indicators management uses as a
basis for evaluating our financial performance. We believe that
these non-GAAP financial measures, when considered together with
our GAAP financial results, provide management and investors with
an additional understanding of our business operating results,
including underlying trends.
These non-GAAP financial measures are not meant to be considered
in isolation or as a substitute for comparable GAAP measures;
should be read in conjunction with our unaudited condensed
consolidated financial statements prepared in accordance with GAAP;
have no standardized meaning prescribed by GAAP; and are not
prepared under any comprehensive set of accounting rules or
principles. In addition, from time to time in the future there may
be other items that we may exclude for purposes of our non-GAAP
financial measures; and we may in the future cease to exclude items
that we have historically excluded for purposes of our non-GAAP
financial measures. Likewise, we may determine to modify the nature
of its adjustments to arrive at our non-GAAP financial measures.
Because of the non-standardized definitions of non-GAAP financial
measures, the non-GAAP financial measures as used by us in this
report have limits in their usefulness to investors and may be
calculated differently from, and therefore may not be directly
comparable to, similarly titled measures used by other
companies.
The following tables reconcile our financial measure for income
(loss) from operations, net loss and earnings (loss) per share
("EPS") for basic and diluted weighted average shares as reported
in our condensed consolidated statement of operations to a non-GAAP
presentation as adjusted for the non-cash stock-based compensation
expense and non-cash gain (loss) on foreign currency transactions
for the periods presented:
|
Three Months |
|
|
Six Months |
|
|
Ended June 30, |
|
|
Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
(In thousands except per share data) |
|
GAAP Income (loss) from operations |
$ |
1,721 |
|
|
$ |
(20,454 |
) |
|
$ |
(4,277 |
) |
|
$ |
(41,710 |
) |
Increase (decrease) for
excluded non-cash items: |
|
|
|
|
|
|
|
|
|
|
|
Stock
compensation |
|
5,580 |
|
|
|
4,422 |
|
|
|
9,235 |
|
|
|
7,228 |
|
Loss (gain)
on foreign currency transaction |
|
251 |
|
|
|
(4,503 |
) |
|
|
1,205 |
|
|
|
(6,486 |
) |
Non-GAAP income (loss) from
operations |
$ |
7,552 |
|
|
$ |
(20,535 |
) |
|
$ |
6,163 |
|
|
$ |
(40,968 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net
loss |
$ |
(5,265 |
) |
|
$ |
(29,023 |
) |
|
$ |
(15,060 |
) |
|
$ |
(55,021 |
) |
Increase (decrease) for
excluded non-cash items: |
|
|
|
|
|
|
|
|
|
|
|
Stock
compensation |
|
5,580 |
|
|
|
4,422 |
|
|
|
9,235 |
|
|
|
7,228 |
|
Loss (gain)
on foreign currency transaction |
|
251 |
|
|
|
(4,503 |
) |
|
|
1,205 |
|
|
|
(6,486 |
) |
Gain on
available-for-sale securities |
|
(932 |
) |
|
|
— |
|
|
|
(932 |
) |
|
|
— |
|
Non-GAAP net loss |
$ |
(366 |
) |
|
$ |
(29,104 |
) |
|
$ |
(5,552 |
) |
|
$ |
(54,279 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per
share - basic and diluted |
$ |
(0.02 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.22 |
) |
Increase (decrease) for
excluded non-cash items: |
|
|
|
|
|
|
|
|
|
|
|
Stock
compensation |
|
0.02 |
|
|
|
0.02 |
|
|
|
0.03 |
|
|
|
0.03 |
|
Loss (gain)
on foreign currency transaction |
|
0.00 |
|
|
|
(0.02 |
) |
|
|
0.00 |
|
|
|
(0.03 |
) |
Gain on
available-for-sale securities |
|
0.00 |
|
|
|
0.00 |
|
|
|
0.00 |
|
|
|
0.00 |
|
Non-GAAP net loss per share -
basic and diluted |
$ |
0.00 |
|
|
$ |
(0.11 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares -
basic and diluted |
|
265,626 |
|
|
|
253,644 |
|
|
|
264,802 |
|
|
|
252,775 |
|
Conference Call
MannKind will host a conference call and presentation webcast to
discuss these results today at 5:00 p.m. Eastern Time. Those
interested in listening to the conference call live via the
Internet may do so by visiting the Company’s website at
mannkindcorp.com under Events & Presentations. A replay will be
available on MannKind's website for 14 days.
About MannKind
MannKind Corporation (Nasdaq: MNKD) focuses on the development
and commercialization of inhaled therapeutic products for patients
with endocrine and orphan lung diseases.
We are committed to using our formulation capabilities and
device engineering prowess to lessen the burden of diseases such as
diabetes, pulmonary arterial hypertension (PAH) and nontuberculous
mycobacterial (NTM) lung disease. Our signature technologies –
dry-powder formulations and inhalation devices – offer rapid and
convenient delivery of medicines to the deep lung where they can
exert an effect locally or enter the systemic circulation.
With a passionate team of Mannitarians collaborating nationwide,
we are on a mission to give people control of their health and the
freedom to live life.
Please visit mannkindcorp.com to learn more, and follow us on
LinkedIn, Facebook, Twitter or Instagram.
Forward-Looking Statements
Statements in this press release that are not statements of
historical fact are forward-looking statements that involve risks
and uncertainties. These statements include, without
limitation, statements regarding the optimization of our commercial
operations for Afrezza and V-Go and the potential for our Endocrine
Business Unit to reach profitability starting in 2024. Words such
as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”,
“goal”, “potential” and similar expressions are intended to
identify forward-looking statements. These forward-looking
statements are based upon MannKind’s current expectations. Actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of
various risks and uncertainties, which include, without limitation,
risks associated with manufacturing and supply, risks associated
with product commercialization, risks associated with developing
product candidates, risks associated with MannKind’s ability to
manage its existing cash resources or raise additional cash
resources, and other risks detailed in MannKind’s filings with the
Securities and Exchange Commission (“SEC”), including under the
“Risk Factors” heading of its Annual Report on Form 10-K for the
year ended December 31, 2022, filed with the SEC on February
23, 2023, and under the “Risk Factors” heading of its Quarterly
Report on Form 10-Q for the quarter ended June 30, 2023, being
filed with the SEC later today. You are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this press release. All forward-looking
statements are qualified in their entirety by this cautionary
statement, and MannKind undertakes no obligation to revise or
update any forward-looking statements to reflect events or
circumstances after the date of this press release.
Tyvaso DPI is a trademark of United Therapeutics
Corporation.
AFREZZA, MANNKIND, and V-GO are registered trademarks of
MannKind Corporation.
MannKind Contact:Rose Alinaya, Investor
Relations(818) 661-5000IR@mannkindcorp.com
MANNKIND CORPORATION AND
SUBSIDIARY CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(In thousands except per share data) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue – commercial product sales |
|
$ |
18,345 |
|
|
$ |
12,722 |
|
|
$ |
35,907 |
|
|
$ |
22,548 |
|
Revenue – collaborations and services |
|
|
11,211 |
|
|
|
5,868 |
|
|
|
22,597 |
|
|
|
8,034 |
|
Royalties – collaborations |
|
|
19,055 |
|
|
|
304 |
|
|
|
30,733 |
|
|
|
304 |
|
Total revenues |
|
|
48,611 |
|
|
|
18,894 |
|
|
|
89,237 |
|
|
|
30,886 |
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
5,224 |
|
|
|
4,617 |
|
|
|
10,754 |
|
|
|
6,901 |
|
Cost of revenue – collaborations and services |
|
|
9,013 |
|
|
|
8,298 |
|
|
|
19,696 |
|
|
|
17,012 |
|
Research and development |
|
|
6,453 |
|
|
|
4,893 |
|
|
|
12,058 |
|
|
|
8,429 |
|
Selling |
|
|
14,002 |
|
|
|
15,868 |
|
|
|
27,312 |
|
|
|
28,596 |
|
General and administrative |
|
|
11,947 |
|
|
|
10,175 |
|
|
|
22,489 |
|
|
|
18,144 |
|
Loss (gain) on foreign currency transaction |
|
|
251 |
|
|
|
(4,503 |
) |
|
|
1,205 |
|
|
|
(6,486 |
) |
Total expenses |
|
|
46,890 |
|
|
|
39,348 |
|
|
|
93,514 |
|
|
|
72,596 |
|
Income (loss) from
operations |
|
|
1,721 |
|
|
|
(20,454 |
) |
|
|
(4,277 |
) |
|
|
(41,710 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,547 |
|
|
|
516 |
|
|
|
2,849 |
|
|
|
893 |
|
Interest expense on financing liability |
|
|
(2,449 |
) |
|
|
(2,443 |
) |
|
|
(4,873 |
) |
|
|
(4,814 |
) |
Interest expense |
|
|
(6,873 |
) |
|
|
(6,642 |
) |
|
|
(9,659 |
) |
|
|
(9,390 |
) |
Gain on available-for-sale securities |
|
|
932 |
|
|
|
— |
|
|
|
932 |
|
|
|
— |
|
Other expense |
|
|
(143 |
) |
|
|
— |
|
|
|
(32 |
) |
|
|
— |
|
Total other expense |
|
|
(6,986 |
) |
|
|
(8,569 |
) |
|
|
(10,783 |
) |
|
|
(13,311 |
) |
Loss before income tax
expense |
|
|
(5,265 |
) |
|
|
(29,023 |
) |
|
|
(15,060 |
) |
|
|
(55,021 |
) |
Benefit from income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(5,265 |
) |
|
$ |
(29,023 |
) |
|
$ |
(15,060 |
) |
|
$ |
(55,021 |
) |
Net loss per share – basic and
diluted |
|
$ |
(0.02 |
) |
|
$ |
(0.11 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.22 |
) |
Weighted average shares used
to compute net loss per share – basic and diluted |
|
|
265,626 |
|
|
|
253,644 |
|
|
|
264,802 |
|
|
|
252,775 |
|
MANNKIND CORPORATION AND
SUBSIDIARY CONDENSED CONSOLIDATED BALANCE
SHEETS
|
|
|
|
|
|
|
|
|
June 30, 2023 |
|
|
December 31, 2022 |
|
|
|
(In thousands except share and per share
data) |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,184 |
|
|
$ |
69,767 |
|
Short-term investments |
|
|
58,163 |
|
|
|
101,079 |
|
Accounts receivable, net |
|
|
27,789 |
|
|
|
16,801 |
|
Inventory |
|
|
25,290 |
|
|
|
21,772 |
|
Prepaid expenses and other current assets |
|
|
32,807 |
|
|
|
25,477 |
|
Total current assets |
|
|
230,233 |
|
|
|
234,896 |
|
Property and equipment, net |
|
|
69,510 |
|
|
|
45,126 |
|
Goodwill |
|
|
1,931 |
|
|
|
2,428 |
|
Other intangible asset |
|
|
1,113 |
|
|
|
1,153 |
|
Long-term investments |
|
|
2,282 |
|
|
|
1,961 |
|
Other assets |
|
|
8,353 |
|
|
|
9,718 |
|
Total assets |
|
$ |
313,422 |
|
|
$ |
295,282 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' DEFICIT |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
17,127 |
|
|
$ |
11,052 |
|
Accrued expenses and other current liabilities |
|
|
36,833 |
|
|
|
35,553 |
|
Financing liability – current |
|
|
9,686 |
|
|
|
9,565 |
|
Midcap credit facility – current |
|
|
16,667 |
|
|
|
— |
|
Deferred revenue – current |
|
|
3,489 |
|
|
|
1,733 |
|
Recognized loss on purchase commitments – current |
|
|
13,164 |
|
|
|
9,393 |
|
Total current liabilities |
|
|
96,966 |
|
|
|
67,296 |
|
Mann Group convertible note |
|
|
8,829 |
|
|
|
8,829 |
|
Accrued interest – Mann Group
convertible note |
|
|
55 |
|
|
|
55 |
|
Financing liability – long
term |
|
|
94,395 |
|
|
|
94,512 |
|
Midcap credit facility – long
term |
|
|
22,811 |
|
|
|
39,264 |
|
Senior convertible notes |
|
|
226,124 |
|
|
|
225,397 |
|
Recognized loss on purchase
commitments – long term |
|
|
56,063 |
|
|
|
62,916 |
|
Operating lease liability |
|
|
4,646 |
|
|
|
5,343 |
|
Deferred revenue – long term |
|
|
60,248 |
|
|
|
37,684 |
|
Milestone liabilities |
|
|
3,772 |
|
|
|
4,524 |
|
Total liabilities |
|
|
573,909 |
|
|
|
545,820 |
|
Stockholders' deficit: |
|
|
|
|
|
|
Undesignated preferred stock,
$0.01 par value – 10,000,000 shares authorized; no shares
issued or outstanding as of June 30, 2023 and December 31,
2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value –
800,000,000 and 400,000,000 shares authorized as of June 30,
2023 and December 31, 2022, respectively, and 268,235,145 and
263,793,305 shares issued and outstanding as of June 30, 2023
and December 31, 2022, respectively |
|
|
2,682 |
|
|
|
2,638 |
|
Additional paid-in capital |
|
|
2,968,917 |
|
|
|
2,964,293 |
|
Accumulated other comprehensive
income |
|
|
443 |
|
|
|
— |
|
Accumulated deficit |
|
|
(3,232,529 |
) |
|
|
(3,217,469 |
) |
Total stockholders' deficit |
|
|
(260,487 |
) |
|
|
(250,538 |
) |
Total liabilities and stockholders' deficit |
|
$ |
313,422 |
|
|
$ |
295,282 |
|
MannKind (NASDAQ:MNKD)
過去 株価チャート
から 4 2024 まで 5 2024
MannKind (NASDAQ:MNKD)
過去 株価チャート
から 5 2023 まで 5 2024